FDA.reportPublic FDA data

Balamine

Product NDC
63162-508
11-digit product format
631620508
Labeler code
63162
Product ID
63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Ballay Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-23
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63162-508-162019-11-27C16284748780-19855e2a2-43aa-60a7-e053-dbdaa90a05bdBalamine DM Syrup
63162-508-202019-11-27C16284748780-19855e2a2-43aa-60a7-e053-dbdaa90a05bdBalamine DM Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63162-508-16BalamineDM Syrup473 mL in 1 BOTTLELIQUID4732
63162-508-20BalamineDM Syrup6 in 1 TRAYLIQUID62
63162-508-20BalamineDM Syrup20 mL in 1 BOTTLELIQUID202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63162-508-16ML - Milliliter63162-50864a72b5c-ddb3-4db8-abe8-b16d566d56a212013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63162-508BALAMINE DM SYRUP (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]2Legacy NDC, 3 package rows20131231_9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae52
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae52
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63162-508-1663162050816473 mL in 1 BOTTLE473 mlHistorical
63162-508-20631620508206 in 1 TRAYHistorical